United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)
PCP Header Box
Addition of 'Peppermint Flavour'
at request of Marketing
MHRA Header Box
Landscape peelable label
65 x 170mm
Keyline (Does not print)
Text free area (Does not print)
Care Chlorhexidine Digluconate 0.2%
w/v Antiseptic Mouthwash
Helvetica Neue LT
Treats & prevents gum disease
Digluconate 0.2% w/v
IMPORTANT: Peel this label
at corner and read BEFORE
use. Do not tear off, re-fix for
For the treatment and prevention of gingivitis
(gum disease), gum ulceration, oral thrush,
denture sores and for maintaining oral
Use the solution only in the mouth. Do not
Adults, the elderly and children:
Measure 10ml in the cup provided.
Rinse the mouth thoroughly for about
1 minute, then spit out.
Use twice a day.
Gingivitis (gum disease): Use as above for
Mouth ulcers and thrush: Use as above,
continuing for 2 days after symptoms go.
Denture sores: Use as above, also soak
dentures for 15 minutes, twice a day.
If symptoms persist, stop use and
consult your doctor or dentist.
Peel where shown for further
Active ingredient: chlorhexidine digluconate
Also contains: ethanol, castor oil polyoxyl
hydrogenated, menthol, peppermint oil,
aspartame (E951) and purified water.
Alcohol 7 vol%.
Do not store above 25°C. Once opened use
within 28 days.
Keep out of the sight and reach of children.
Manufactured by the licence holder Thornton
and Ross Ltd., Huddersfield, HD7 5QH, UK.
PL 00240/0118 PIP: 300-7994
This mouthwash contains chlorhexidine digluconate,
a disinfectant and antiseptic. It reduces the
formation of dental plaque and fights infection in the
1. Before you use this medicine
Do not take/use the medicine if you or
Are allergic (hypersensitive) to chlorhexidine
gluconate or any of the other ingredients listed on
Special warnings and precautions
This medicine may in rare cases cause severe
allergic reactions, leading to a drop in blood pressure
and even unconsciousness. Early symptoms of a
severe allergic reaction may be skin rash or asthma.
If you notice these symptoms, stop use and contact
your doctor as soon as possible (see under section 2:
Possible side effects).
Take care with the medicine….
Keep away from the eyes and ears.
If the solution comes in contact with the eyes,
rinse well with water.
Toothpastes may stop the mouthwash working
properly if used immediately after the mouthwash.
To prevent this use toothpaste first or at a different
time of day and rinse your mouth before using the
Pregnant or breastfeeding….
Ask your doctor or pharmacist for advice before using
this medicine if you are pregnant, might be pregnant
or are breastfeeding. Chlorhexidine Digluconate
Antiseptic Mouthwash should not be used unless the
doctor has told you to do so.
Important ingredient information
This product contains aspartame, a source of
phenylalanine, which may be harmful for people
It also contains castor oil polyoxyl hydrogenated
which may cause skin reactions.
If you notice the following minor effects it is not
normally necessary to stop use, however, if
concerned talk to your doctor or pharmacist.
Taste changes or a burning sensation on the
tongue when first used. This usually reduces with
Discolouration of the tongue and teeth may occur,
but this is not permanent and may be prevented by
brushing daily with a normal toothpaste before
using the mouthwash and avoiding tannin-containing
foods such as red wine, tea or coffee for at least an
hour after using the mouthwash.
In some cases a scale and polish by your dentist
or hygienist may be necessary to remove the
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.
3. Further information
If you accidentally swallow some see a doctor
straight away. Take the pack with you to show which
medicine you have swallowed.
Do not use after the expiry date. The expiry date
refers to the last day of that month.
Return any unused medicine to the pharmacy for
What the medicine looks like
Chlorhexidine Digluconate Antiseptic Mouthwash is a
colourless liquid with an odour of peppermint.
It is supplied in 300ml bottles.
This label was revised in March 2015
2. Possible side effects
Like all medicines, Chlorhexidine Digluconate
Antiseptic Mouthwash can have side effects, although
these don’t affect everyone.
Possible serious side effects
If you notice any of the following reactions stop use
and get immediate medical help: swelling of the face,
lips, tongue or throat; a red itchy skin rash; wheezing
or difficulty breathing; feeling faint or dizzy; a strange
metallic taste in the mouth; collapse. You may be
having an allergic reaction.
Other possible side effects are:
Swelling of the salivary glands.
Peeling of the skin inside the mouth.
If you notice these side effects, stop use and tell your
doctor or pharmacist. They will tell you what to do.
LOT, MAN & EXP
n t -
a s h
p e p p e r m i n t f l a v o u r
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT
Care Chlorhexidine Digluconate 0.2% w/v Antiseptic Mouthwash
QUALITATIVE AND QUANTITATIVE COMPOSITION
Solution 1.0% v/v)
For excipients see 6.1
A clear, colourless liquid with an odour of menthol and peppermint.
Aids prevention of dental plaque formation. Aids the treatment and prevention of
gingivitis. For the maintenance of oral hygiene. Promotes gingival healing following
periodontal surgery. Management of recurrent oral ulceration. For the treatment of
denture stomatitis and oral thrush.
Posology and method of administration
For oromucosal use.
Adults, the elderly and children: To be used as required up to twice daily. Rinse the
mouth thoroughly for about 1 minute with 10ml. The mouthwash should be expelled
from the mouth after rinsing.
Prior to dental surgery: Rinse the mouth thoroughly with 10ml for 1 minute. The
mouthwash should be expelled from the mouth after rinsing.
Treatment of gingivitis: A course of one month is recommended.
Treatment of denture stomatitis: Soak the denture(s) in solution for 15 minutes twice
Treatment of oral ulceration and oral thrush: Treatment should be continued for 48
hours after clinical resolution.
Known hypersensitivity to the product or any of its components, especially in those with a
history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8).
Special warnings and precautions for use
For oral use only. Keep away from the eyes and ears. If the solution comes into contact with
the eyes, rinse well with water. Keep out of the reach and sight of children. Do not swallow.
If symptoms persist, stop using and consult your doctor or dentist.
Chlorhexidine Mouthwash contains chlorhexidine. Chlorhexidine is known to induce
hypersensitivity, including generalised allergic reactions and anaphylactic shock. The
prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests
this is likely to be very rare. Chlorhexidine Mouthwash should not be administered to anyone
with a potential history of an allergic reaction to a chlorhexidine-containing compound (see
sections 4.3 and 4.8).
Interaction with other medicinal products and other forms of interaction
Chlorhexidine digluconate is incompatible with anionic agents which are usually
present in conventional dentrifices. These should therefore be used before the
mouthwash. Rinse the mouth thoroughly with water before using the mouthwash.
Pregnancy and lactation
No harmful effects in human pregnancy or during lactation have been reported.
Nevertheless like all medicines, care should be exercised and the mouthwash should
only be used on the advice of a doctor or dentist
Effects on ability to drive and use machines
No or negligible influence.
Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema,
rash, urticaria, skin irritation, and blisters.
Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and
A superficial discolouration of the dorsum of the tongue may occur which disappears after
discontinuation of treatment. Discolouration of the teeth and silicate or composite
restorations may also occur. The discolouration is not permanent and may be prevented by
brushing daily with conventional toothpaste prior to using the mouthwash and avoiding
tannin-containing food and drinks. In some cases a professional prophylaxis (scaling and
polishing) may be necessary to completely remove the stain.
Transient disturbances of taste and a burning sensation of the tongue may
occur on initial use of the mouthwash but usually diminishes with continued use.
In cases where oral desquamation occurs it may be necessary to discontinue treatment.
Very occasionally, swelling of the parotid glands during use has been reported. If this
happens stop using the product and the effect should go away.
In all cases spontaneous resolution has occurred on discontinuation of treatment.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow
Care Scheme at: www.mhra.gov.uk/yellowcard.
Chlorhexidine is poorly absorbed by the oral route, therefore systemic effects are
unlikely even if large volumes are swallowed. However, gastric lavage followed by
supportive measures may be used as appropriate.
A01A B03 – Stomatological preparations, antiinfectives for local oral treatment
Chlorhexidine digluconate is a bisbiguanide antiseptic and disinfectant, which is
bactericidal or bacteriostatic against a wide range of gram negative and gram positive
antimicrobial activity covers most of the important species occurring in the oral
Due to its cationic nature, chlorhexidine digluconate binds strongly to skin, mucosa
and other tissues and is thus very poorly absorbed. No detectable blood levels have
been found following oral use.
Preclinical safety data
No data of relevance to the prescriber, which is additional to that included in other
sections of the SPC.
List of excipients
Hydrogenated Polyoxyl Castor Oil
Care Chlorhexidine Antiseptic Mouthwash is incompatible with anionic agents which
mouthwash, rinsing the mouth between applications, or at a different time of day.
Unopened: 2 years
In-use: 28 days
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
300ml amber PET bottle with HDPE/PP tamper evident child resistant closure with
EPE Saranex liner.
30ml CE marked polypropylene dosing cup.
Special precautions for disposal
MARKETING AUTHORISATION HOLDER
Thornton & Ross Limited
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT